ArticleFrontiers in medicine2025
Adverse events associated with Implantable Collamer Lens: insights from the FDA MAUDE database.
Article in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Incremental contribution of Corvis ST dynamic biomechanical parameters to interpretable machine learning prediction of clinician-selected refractive procedures: a retrospective observational study.BMC ophthalmology · 2026Observational
- Intraoperative Hemorrhage during Implantable Collamer Lens Surgery: A Case Report and Management Strategy.Case reports in ophthalmologyArticle
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Implantable Collamer Lens (ICL) implantation is rising globally, yet real-world studies on adverse events (AEs) remain scarce. This study analyses ICL-related complications using the MAUDE database. Methods: Data on ICL-related AEs were extracted from the MAUDE database. Cases were categorized into spherical and toric ICLs based on lens diopter. Descriptive statistics summarized device-related issues and complications, and Cramér's V assessed their associations. Management strategies and resolution rates for common complications were also evaluated. Results: Among 25,001 ICL-related AEs, 43.8% involved spherical ICLs and 56.2% toric ICLs. Common device-related issues included "Shape and/or size problems" (nearly half of annual AEs) and "Off-label use" (around 20%, rising since 2019 and stabilizing). "Operation and control issues" declined steadily since 2019, stabilizing below 3%. Spherical ICL cases with "Activation, positioning, or separation problems" dropped below 1% post-2019, while toric cases remained at 6.9-9.0%. The top three complications-"Vision issues," "Intraocular pressure issues" and "Lens-related issues"-were most frequent, with "No patient impact" in most cases. Moderate correlations were found between complications and ICL-related AEs ( Conclusion: While ICL implantation is generally safe, concerns about inappropriate sizing and off-label use persist. This study suggests that improving lens sizing accuracy and adhering to guidelines may reduce AEs.
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Registered trials
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